A California state judge has rejected Bayer’s arguments for legal immunity, allowing a slate of 11 Essure lawsuits to proceed on multiple counts.
California Essure Lawsuits Move Forward
Hundreds of women have already filed lawsuits over Essure, a controversial sterilization implant that patients say causes horrendous side effects. But the future of these lawsuits has always been in doubt. Essure’s manufacturer, the multinational healthcare company Bayer, argues that its medical device should be immune from product liability lawsuits.
Judge Winifred Y. Smith disagrees. In her decision, handed down on August 2, 2016, the Judge held that the claims of 14 women were not expressly or impliedly preempted under federal or state law.
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Surviving Federal Preemption
Bayer has long argued that its sterilization implant should be protected from personal injury claims, which are usually based in the precepts of state law.
In contrast to the strict federal laws governing pharmaceutical drugs, there’s no specific provision in federal law that allows patients to file personal injury lawsuits against medical device manufacturers. That means injured patients, including women who believe they were harmed by Essure, must instead turn to state laws for legal recourse.
But Essure was approved by the US Food & Drug Administration, a federal agency. What’s more, the FDA used a special approval pathway, reserved solely for “Class III” medical devices, to review the implant’s safety and efficacy.
“The Highest Risk Devices”
Class III medical devices are ones that the agency believes present a significant risk of personal injury or death. As such, these “high-risk” medical devices come under serious scrutiny, and their approval requires far more clinical evidence than products like dental floss or condoms, which belong to Class I and Class II respectively.
For many companies, the demands of securing Class III approval would be financially prohibitive – notwithstanding some sort of added incentive to make the approval process worth their while. In a 2008 decision, the US Supreme Court ruled that this special “Pre-Market Approval,” granted by a federal agency, can override some legal claims that would be justified under state law.
In general, federal laws trump state laws when the two conflict, or make contradictory demands on drug and medical device manufacturers, according to Cornell University Law School. This deference for federal law usually carries over to the dictates of federal agencies that, while not laws in and of themselves, are often given a similar authority.
While cases can still be brought under state laws that mirror federal ones, claims that contradict federal laws, or seek to supplement them with additional requirements, are often said to be “preempted.”
Bayer’s Request For Immunity Rejected
Bayer has returned to this concept of federal preemption time and time again, arguing that any Essure lawsuits based in state law should be thrown out of court.
It was the same line in California, where 14 women who suffered severe Essure side effects filed a total of 11 lawsuits. But Judge Smith, a graduate of Stanford and Boston University, rejected Bayer’s request for immunity. In her decision, Smith decided that the lawsuits would be allowed to proceed on several causes of action:
- Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects
- Claims that Bayer breached Essure’s warranties and misrepresented the device’s safety and efficacy through advertising and promotional materials that were not approved by the FDA
Two other allegations, that Bayer negligently trained implanting physicians and manufactured Essure improperly, could also be able to withstand federal preemption, but Smith says the women must replead those claims, explaining in more detail how Bayer’s alleged misconduct contributed to their personal injuries.
Decision Could Improve Prospects For Other Essure Lawsuits
The decision only applies to 11 Essure lawsuits filed in the Superior Court of California, County of Alameda. But legal experts say the court’s opinion could be a major victory for thousands of other women who have filed their own Essure lawsuits, or plan to do so in the future.
In the span of just four months, between April and July 2016, nearly 500 women filed a series of joint complaints against Bayer in the US District Court for the Eastern District of Pennsylvania. We covered these recent lawsuits in detail here.
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Earlier this year, the FDA added a “black box” warning to Essure, cautioning patients and physicians about the device’s risks. A black box warning is the agency’s highest level of warning, indicating that a product may cause severe injuries or death. Bayer has also been ordered to conduct a new clinical study, research that will evaluate the potential dangers of Essure in “real world” settings.